Device Listing 1677425419

Listing Summary#

Listing key
1677425419
Premarket submission
K252493
Device
NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica)
Applicant
Hycor Biomedical
Product code
DHB
Decision date
2025-12-23